Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection

Completed · Phase 3

Conditions studied: Graft Rejection

In brief

This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.

Key facts

Study ID

NCT00300274

Run by

Novartis Pharmaceuticals

People needed

721

Starts

2006-01-01

Expected to finish

2011-07-01

Last updated by the study team

2012-08-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation.
• The graft must be functional at time of randomization.

You may not qualify if…

• Patients who are recipients of multiple solid organ transplants or tissue transplants or have previously received organ transplants.
• Patients who are recipients of ABO incompatible transplants.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• California Pacific Medical Center — San Francisco, California, United States
• Stanford U Sch, Falk Cardiovasular Research Ctr. — Stanford, California, United States
• University of Florida Shands Hospital — Gainesville, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Loyola Univerisity Medical School — Maywood, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Recanati Miller Transplant Institute — New York, New York, United States
• UNC Division of Cardiology — Chapel Hill, North Carolina, United States
• Duke University Heart Failure Research — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Penn State College of Medicine — Hershey, Pennsylvania, United States
• Hahnemann University Hospital — Philadelphia, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Cardiovascular Consultants — Austin, Texas, United States
• University of Texas Medical Branch, Div of Cardio Thoracic — Galveston, Texas, United States
• Methodist Hospital/DeBakey Heart Failure Research Center — Houston, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• University of Wisconsin - Madison Medical School — Madison, Wisconsin, United States
• UCLA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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